BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE

K990284 · Baylis Medical Co., Inc. · DXF · Feb 1, 2001 · Cardiovascular

Device Facts

• Record ID: K990284
• Device Name: BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE
• Applicant: Baylis Medical Co., Inc.
• Product Code: DXF · Cardiovascular
• Decision Date: Feb 1, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5175
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To create an atrial septal defect in the heart. Transseptal left heart access.

Device Story

Baylis Medical RF Septostomy System creates atrial septal defects and facilitates transseptal left heart access. System utilizes radiofrequency (RF) energy to penetrate cardiac tissue. Operated by physicians in clinical/surgical settings. Device provides controlled tissue ablation to enable catheter passage between heart chambers. Benefits include precise access for interventional procedures requiring left heart entry.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

RF energy-based ablation system for cardiac tissue penetration. System components include an RF generator and specialized catheter for transseptal access. Operates via controlled electrical energy delivery to create precise septal defects.

Indications for Use

Indicated for patients requiring the creation of an atrial septal defect and transseptal left heart access.

Regulatory Classification

Identification

A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB = 1 2001

Mr. Kris Shah Baylis Medical Co., Inc. 5160 Explorer Drive, Unit 33 Mississauga, Ontario, Canada L4W 4T7

K990284 Re:

Trade Name: Baylis Medical RF Septostomy System Regulatory Class: II (two) Product Code: DXF Dated: November 15, 2000 Received: November 16, 2000

Dear Mr. Shah:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your Section 5 ro(x) notification of equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstant commerce stated in the enclosure) to legally manacted processor of the Medical Device American of the American Commend pror to May 20, 1910, the chareas with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act). " Fournal), and controls provisions of the Act include requirements for provisions of the Act. "The general control contracturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (Fremarket Applovar), it may of below of Federal Regulations, Title 21, Parts 800 to allecting your device can or reacle ermination assumes compliance with the Current Good 897. A substainmally oqui rains as set forth in the Quality System Regulation (QS) for Manufacturing Fractice requiration (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mispections, the rood and Drug Hammesult in regulatory action. In addition, FDA may publish comply with the GHT Togation in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might response to your premarter nouts 42 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Kris Shah

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, (201) 594-156. Tracklent Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address ".http://www.fda.gov/cdrh/dsmain.html".

Sincerely yours,

Stam Katerpus

James E. Dillard MI Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K990284

Device Name: Baylis Medical RF Septostomy System

Indications For Use:

To create an atrial septal defect in the heart. Transseptal left heart access.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use-(Per 21 CFR 801.109)

OR

Over-The-Counter Use" .

(Optional Format 1-2-96)

Stuse Portocarrero 2-1-1

Division of Cardiovascular & Respiratory Devices
510(k) Number K990284